If approved, the treatment would be indicated for patients with acute pain who require an opioid.
The US Food and Drug Administration (FDA) has delayed a decision on intravenous tramadol as a treatment for patients in acute pain who require an opioid.
On April 13, a day after the expected Prescription Drug User Fee Act (PDUFA) date, the FDA announced they are still reviewing Avenue Therapeutics New Drug Application (NDA) for IV tramadol and had not provided an ultimate decision on the application.
In February, the FDA acknowledges they had received the NDA for the treatment following an October 9 Complete Response Letter (CRL) on the original application and a Type A meeting with FDA officials. The resubmission package included revised language relating to the proposed product label, with a report relating to terminal sterilization validation.
The original NDA included data from phase 3 clinical trials showing statistically significant outcomes for all primary endpoints, as well as several of the secondary endpoints.
However, in the CRL, the FDA said the treatment is not safe for the patient population it is intended to treat.
The FDA said if a patient requires an analgesic between the first dose of IV tramadol and the onset of analgesia, a rescue analgesic is needed. This would likely mean the patient would need another opioid, resulting in opioid “stacking.”
Ultimately, this scenario would increase the likelihood of opioid-related adverse effects.
The FDA also did not identify a safety signal in the clinical development program for the treatment and is requiring an adequate terminal sterilization validation prior to approval of the NDA. Avenue state the terminal sterilization validation is planned for completion by the end of the year.